Associate Director, CMC Drug Substance

About the job

Position Description:

Latigo is searching for an Associate Director CMC, Drug Substance. Reporting to the Senior Director of Drug Substance and Development, the Associate Director will assist in the process development and cGMP drug substance manufacturing for Latigo’s small molecule clinical pipeline.

Job responsibilities

• Lead drug substance development activities for New Chemical Entity programs from preclinical through clinical and commercial stages.

• Design, optimize, and scale synthetic routes with a focus on efficiency, robustness, cost, and sustainability.

• Provide expert input on impurity control strategies, starting material selection, and control of critical process parameters.

• Contribute to overall CMC development strategy and timelines for assigned programs.

• Author, review, and support drug substance sections of regulatory submissions (IND, CTA, NDA, IMPD)

• Manage and oversee activities at Contract Development and Manufacturing Organizations, including route scouting, process transfer, scale-up, cGMP manufacturing, and troubleshooting.

• Ensure effective communication, technical oversight, and performance management of external partners.

• Manage and review deviation events and investigations in coordination with CMC counterparts, QA and regulatory team members

• Represent drug substance function in CMC teams and project meetings, and work closely with cross-functional teams to meet project timelines and goals

Experience and Required Skills:

• Ph.D. or M.S. degree in Chemistry or Chemical Engineering, and at least 5 years of hands-on experience in small molecule drug development.

• Strong understanding of organic synthesis and ability to direct and guide the work of Contract Development and Manufacturing Organizations.

• Strong understanding of cGMP regulations and manufacturing.

• Early-stage development of pre-clinical and clinical Active Pharmaceutical Ingredients experience is highly desirable.

• Prior experience in managing either internal or external projects is a plus.

Additional Skills/Preferences:

• Familiarity with US and international regulatory CMC guidance and processes.

• Prior experience filing INDs and NDA experience is a plus.

• Strong team player with excellent written and verbal communication skills.

• Excellent computer skills (e.g., ChemDraw, Microsoft Office, etc.)

• Strong organizational skills with attention to detail and ability to manage multiple projects at once.

• Ability to work both independently and in a team focused environment.

• Limited travel (less than 20%) may be required.